MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CR FB INSRT SZ 9 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151620908
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	11/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Removal of knee joint implants and insertion of cement spacer; attune implants were removed due to infection and not because they had failed.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Evaluation of the returned device identified polyethylene wear.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CR FB INSRT SZ 9 8MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork IN ; EI
• MDR Report Key: 8161312
• Report Number: 1818910-2018-78110
• Device Sequence Number: 16693902
• Product Code: JWH
• UDI-Device Identifier: 10603295046158
• UDI-Public: 10603295046158
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 151620908
• Device Lot Number: 525441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Initial Date Received by Manufacturer: 11/18/2018
• Supplement Date Received by Manufacturer: 01/10/2019; 01/10/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 02/01/2019; 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention